DIN EN ISO 14155:2021 Edition

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Clinical investigation of medical devices for human subjects – Good clinical practice

Published By	Publication Date	Number of Pages
DIN	2021-05	98

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Categories: 11.100.20 - Biological evaluation of medical devices, DIN

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Description

This standard addresses the technical aspects of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes by defining good clinical practices for their design, conduct, recording and reporting of clinical investigations. It specifies general requirements intended to – protect the rights, safety and well-being of human subjects, – ensure the scientific conduct of the clinical investigation and the credibility of the investigation results, – assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This standard 14155 is not applicable to in vitro diagnostic medical devices.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2021-05
Pages Count	98
Language	Germany
Descriptors	Best practice, CE marking, Clinical investigations, Clinical testing, Conformity assessment, Control charts, Definitions, Dental equipment, Dental instruments, Documentation, Efficiency, Enterprises, Ethics, Evaluations, Human body, Implants (surgical), Information, Inspectors, Law, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Monitoring, People, Performance testing, Reports, Results, Safety, Specification (approval), Surgical implants, Surgical instruments, Surveillance (approval), Systemology, Test persons, Testing, Trials, Utilization
File Size	2.1 MB
ICS Codes	11.100.20 - Biological evaluation of medical devices

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DIN EN ISO 14155:2021 Edition

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